510(k) K193039

Single Use Balloon Dilator V (with knife) by Olympus Medical Systems Corp. — Product Code KNS

K193039 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Balloon Dilator V (with knife)". The FDA issued a decision of Substantially Equivalent on Dec 17, 2019. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Olympus Medical Systems Corp. has 103 other 510(k) clearances on record.